Enterra® II 37800 (UDI 00763000449704)Recalls & reported problems

Summary

The FDA's MAUDE database contains 359 adverse event reports that list this exact device (DI 00763000449704), received between Jul 13, 2021 and Aug 5, 2025 — classified as 16 deaths, 222 injuries, 121 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (112 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 359 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATES SHE HAS AN ENTERRA DEVICE IN HER STOMACH, AND IT'S GIVING HER EXTREME PAIN AND SHE WOULD LIKE IT REMOVED TODAY. PATIENT REPORTING SIDE EFFECTS POST IMPLANT. PATIENT REPORTS THAT HER STOMACH IS GIVING HER GRIEF AND SHE HAS BEEN HAVING ACHES, PAINS, JOLTS SINCE HER DEVICE WAS PLACED. SHE WANTS IT OUT OF HER BODY ASAP. SHE REPORTS THAT SHE HAS NOTIFIED HER HCP AND THAT PROVIDER ADJUSTED IT FIRST, THEN LATER TURNED IT OFF. HOWEVER, SHE REPORTS THAT SHE CONTINUES TO EXPERIENCE THESE SYMPTOMS. SHE HAS CALLED FOR A FOLLOW UP APPT AND STATES THAT SHE IS SCHEDULED FOR (B)(6) WHICH IS THE EARLIEST AVAILABLE. ENCOURAGED PATIENT TO CONTACT OFFICE TO EXPLAIN HER SYMPTOMS AND ASK ABOUT SOONER APPT AVAILABILITY.

  Patient problems: Electric Shock

  MAUDE report 22718951 ↗
• InjuryJul 30, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED IN AND REPORTED THAT THEY HAD A RETURN OF N/V SYMPTOMS, THEY ARE HOME SICK AND NOT EATING. IF THEY EAT, THEY ARE NAUSEOUS AND VOMITING. PATIENT SAID THEY THINK THE BATTERY IS DEAD AND THE DEVICE HAD LASTED FOR 2 YEARS AND THEY THOUGHT IT WOULD LAST 5 YEARS.

  Patient problems: Failure of Implant

  MAUDE report 22666425 ↗
• InjuryJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT REPORTS THAT SHE WAS IMPLANTED ON (B)(6) 2022 BY DR (B)(6). STATES SHE HAS BEEN HAVING RECURRENCE OF SYMPTOMS AND BURNING NEAR DEVICE SITE. SHE DENIES HAVING A DEVICE CARD AND NO IMPLANT RECORD FOUND IN CRM. SHE PLANS TO F/U WITH SURGEON. PATIENT EXPLANTED DUE TO DISCOMFORT AND RETURN OF N/V SYMPTOMS.

  Patient problems: Failure of Implant

  MAUDE report 22650370 ↗
• MalfunctionJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT/PHYSICIAN CALLED TO REQUEST THE DEVICE BE INTERROGATED. WHILE THERE THE PATIENT REPORTED AN INCREASE IN NAUSEA AND THE UPON INTERROGATION THE DEVICE SHOWED HIGH IMPEDANCE. PATIENT IS BEING REFERRED TO DR JOHNSON MANN, SURGEON. PATIENT REPORTS NO TRAUMA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22649954 ↗
• MalfunctionJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  SHOCKING AT LEADS SITE. THE PATIENT REPORTED EXPERIENCING SHOCK AT THE SITE OF LEAD INSERTION. SURGEON AND PATIENT OPTED FOR A FULL EXPLANT AND DECIDED NOT TO REIMPLANT DUE TO THE PATIENT BEING ON LOW SETTINGS AND NO LONGER NEEDING THE DEVICE, WITH NO SYMPTOMS OF GP.

  Patient problems: Electric Shock

  MAUDE report 22648884 ↗
• InjuryJul 29, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SURGEON REPORTED THE ISSUE: COMPLETE SYSTEM REMOVAL DUE TO LEAD EROSION AND CHRONIC SEROMA OF THE GENERATOR POCKET. NO NEW SYSTEM WAS IMPLANTED AT THAT TIME, THE PROVIDER AND PATIENT WILL DECIDE AFTER HEALING IF A NEW SYSTEM WILL BE IMPLANTED.

  Patient problems: Erosion

  MAUDE report 22645672 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEADS INADVERTENTLY CUT DURING UNRELATED GP SURGERY (KIDNEY TRANSPLANT). PATIENT SYMPTOMS HAVE BEEN WORSENING EXPONENTIALLY IN THE LAST 6 MONTHS WITHOUT THERAPY (POST LEADS DAMAGE), WITH THE PATIENT BEING ADMITTED TO THE HOSPITAL AND REQUIRING IV FLUIDS INFUSION AT HOME. DURING A KIDNEY TRANSPLANT SURGERY, BOTH LEADS WERE INADVERTENTLY CUT. THE TRANSPLANT TEAM INFORMED THE IMAGING PHYSICIAN. REPLACEMENT WAS DELAYED FOR THE PATIENT TO RECOVER FROM THE TRANSPLANT. A NEW ENTERRA SYSTEM WAS IMPLANTED ON (B)(6) 2025. THE PATIENT TOLERATED THE PROCEDURE WELL, WHICH WAS PERFORMED OPEN DUE TO THE PRESENCE OF A LARGE AMOUNT OF ADHESIONS. PATIENT HAD LEADS CUT ACCIDENTALLY DURING A NON-RELATED PROCEDURE; LATER REVISED TO REPLACE ENTIRE SYSTEM.

  Patient problems: Failure of Implant

  MAUDE report 22644347 ↗
• InjuryJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  THE DEVICE IS SHOCKING THE PATIENT. PATIENT LEFT ER WITHOUT TREATMENT; NO FURTHER ACTION TO BE TAKEN UNLESS PATIENT RETURNS TO ER.

  Patient problems: Electric Shock

  MAUDE report 22510235 ↗
• InjuryJul 15, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. PATIENT EXPLANTED (B)(6) 2023.

  Patient problems: Failure of Implant

  MAUDE report 22509805 ↗
• InjuryJul 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  FROM THE CALL CENTER: MY HUSBAND NEEDS HIS STIMULATOR INTERROGATED. IT'S BEEN 10 YEARS SINCE IT WAS PLACED IN SEATTLE. HE'S BEEN HAVING ISSUES SINCE (B)(6) & BEEN IN & OUT OF HOSPITAL. HE'S IN SEVERE PAIN, NAUSEOUS, VOMITING & DISORIENTED. PATIENT NEEDED NEW BATTERY; EXPLANTED BATTERY WAS DISPOSED THEREFORE NO ANALYSIS POSSIBLE.

  Patient problems: Failure of Implant

  MAUDE report 22469009 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT CALLED THE PATIENT LIAISON LINE AND LEFT A VOICEMAIL STATING, "I HAD AN ENTERRA THERAPY PLACED ON (B)(6) AND WAS DOING FINE BUT STILL FEELING THE STIMULATION. SO WENT DOWN THE VOLTAGE A WEEK AND A HALF AGO, FEW DAYS LATER I SORT OF FEELING THE FIRING, THE STIMULATION AGAIN. PUT ME ON MUSCLE RELAXERS A LOT AND I CAN'T TAKE THAT MUCH. IT'S NOT HELPING, STILL FEELING THE STIMULATION AND NOW I HAVE A HARD, LIKE KNOT FEELING, ALL AROUND IN MY ABDOMEN, AROUND THE PACEMAKER. IT'S PRETTY UNCOMFORTABLE. I DID PLACE A CALL INTO THE NURSE AT MY SURGEON'S OFFICE WAITING ON A RETURN CALL. I DID HAVE TO CALL AN ON-CALL HOSPITAL DOCTOR THIS WEEKEND AND THEY TOLD ME TO CALL DR. (B)(6)." PATIENT UNDERWENT AN EXPLORATORY SURGERY ON (B)(6) 2025 WITH DR (B)(6). SHE HAD A SMALL SEROMA. THE DEVICE WAS IN THE FLUID. DR (B)(6) TESTED THE SECURITY OF THE LEADS, AND THEY WERE STILL SECURE. HE DISCONNECTED THE LEADS AND SAID THERE APPEARED TO BE FLUID IN THE FLUID IN THE HEADER BY THE SET SCREWS. DR (B)(6) CLEANED OUT THE POCKET AND THEN TOOK GAUZE TO CLEAN OUT THE HEADER PORTS. HE WAS UNABLE TO GUARANTEE THAT ALL FLUIDS HAD BEEN REMOVED, SO HE DECIDED TO REPLACE THE GENERATOR. THE REGISTRATION HAS B

  Patient problems: Failure of Implant

  MAUDE report 22417387 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT STATES HER ENTERRA THERAPY BATTERY DIED. SHE STATES SYMPTOMS GOT WORSE THE 3RD WEEK OF MARCH WHEN SHE STARTED VOMITING CONSTANTLY. SHE STATES SHE SPENT THE LAST WEEK IN THE HOSPITAL. SHE STATES HER BATTERY IS ONLY LASTING ABOUT 1 YEAR DUE TO HIGH SETTINGS PER PATIENT. SHE STATES SHE IS A PATIENT OF DR. KURIAN WHO IS RETIRING, BUT STATES SHE IS WORKING WITH ANOTHER PROVIDER IN THE OFFICE WHO IS WORKING ON A PREAUTHORIZATION FOR REPLACEMENT SURGERY. PATIENT WAS TRANSFERRED TO TECH SERVICES. PATIENT EXPERIENCED RETURN OF N/V SYMPTOMS DUE TO BATTERY DEPLETION; BATTERY REPLACED; EXPLANTED IPG WAS DISPOSED OF. NO FURTHER ACTION TO BE TAKEN.

  Patient problems: Failure of Implant

  MAUDE report 22413622 ↗
• InjuryJul 7, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  FROM THE CALL CENTER: I DON'T KNOW IF MY BATTERY IN MY STIMULATOR IS LOW OR NOT, I NEED TO MAKE ARRANGEMENTS TO SEE IF THE BATTERY SHOULD BE REPLACED. I TAKE NAUSEA MEDICINE, ZOFRAN BUT IT'S NOT WORKING THIS WEEK. ID # (B)(6). PATIENT HAD BATTERY EXCHANGED. EXPLANTED BATTERY WAS DISPOSED OF THEREFORE NO ANALYSIS POSSIBLE. NO FURTHER ACTION TO BE TAKEN.

  Patient problems: Abdominal Pain; Failure of Implant

  MAUDE report 22413124 ↗
• InjuryJul 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  FROM THE CALL CENTER: I AM CALLING ABOUT A BATTERY REPLACEMENT FOR A NEUROSTIMULATOR. PATIENT FELT DEVICE WASN'T HELPING AND HAD IT REPLACED; ENDED UP WITH INFECTION OF NEW DEVICE WHICH WAS THEN EXPLANTED TO ALLOW INFECTION TO RESOLVE.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 22372709 ↗
• DeathJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT DEATH. PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. CHECKED IN AT MDT (B)(6) 2025. MDT RECORD ID: (B)(4). AS REPORTED EVENT DESCRIPTION: PATIENT DEATH. CAUSE OF DEATH: PENDING FURTHER STUDIES. (LEADS RECEIVED CONNECTED TO DEVICE AND SEGMENTED AT PROXIMAL END). REPORTED IN DATABASE ONLY; WAITING FOR DEVICE ANALYSIS FROM MDT. DEVICE EXPLANTED AS A RESULT OF PATIENT DEATH. NO INDICATION THAT PATIENT DEATH WAS DUE TO DEVICE. NO FURTHER ACTION TO BE TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 22372442 ↗
• InjuryJul 1, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  FEELING A STIMULATION/SHOCKING SENSATION IN THEIR ABDOMEN THAT THEY BELIEVE IS COMING FROM THE DEVICE. PATIENT HAS NOT RETURNED TO DR. THOMPSON FOR FOLLOW UP. COMPLAINT TO BE CLOSED WITH NO FURTHER ACTION TAKEN: IF PATIENT DOES SEEK TREATMENT SOME TIME IN THE FUTURE, A NEW ISSUE WILL BE OPENED AT THAT TIME.

  Patient problems: Electric Shock

  MAUDE report 22372053 ↗
• DeathJul 1, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. RECEIVED FROM (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED. ORIGINALLY IMPLANTED ON (B)(6) 2022

  Patient problems: Insufficient Information

  MAUDE report 22371562 ↗
• DeathJul 1, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS: REPORTED IN MEDTRONIC DATABASE. RECEIVED FROM (B)(6) IN (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED. ORIGINALLY IMPLANTED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 22371303 ↗
• DeathJun 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. RECEIVED FROM (B)(6) FUNERAL HOME IN (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED. ORIGINALLY IMPLANTED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 22366754 ↗
• DeathJun 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS - REPORTED IN MEDTRONIC DATABASE. RETURNED FROM (B)(6) FUNERAL HOME IN (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED. ORIGINALLY IMPLANTED ON (B)(6) 2022.

  Patient problems: Insufficient Information

  MAUDE report 22366415 ↗
• DeathJun 30, 2025No Apparent Adverse Event; No Apparent Adverse Event

  PRODUCT RETURNED TO MEDTRONIC FOR ANALYSIS: REPORTED IN MEDTRONIC DATABASE. RECEIVED FROM (B)(6). CODED AS C-500 NON-COMPLAINT AT MEDTRONIC AND CLOSED.

  Patient problems: Insufficient Information

  MAUDE report 22365466 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOCKING AT EPIGASTRIC AREA. THE PATIENT FELL WHEN PLAYING TACKLE FOOTBALL WITH HER SON. AFTER THE INCIDENT THE SHE STARTED TO FEEL A SHOCKING SENSATION IN HER STOMACH AREA. PATIENT WAS SEEN BY THE MANAGING/SURGEON PROVIDER, A FULL SYSTEM EXCHANGE WAS RECOMMENDED AND PERFORMED ON (B)(6) 2025, THERE WERE NO COMPLICATION REPORTED BY PHYSICIAN DURING THE PROCEDURE. THE SYSTEM WAS NOT SENT OUT FOR TESTING DUE TO THE ISSUE ONLY BEING REPORTED AFTER IT WAS ALREADY DISPOSED.

  Patient problems: Electric Shock

  MAUDE report 22323575 ↗
• InjuryJun 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  DEVICE JUST IMPLANTED ON (B)(6) 2025 BUT NEEDED TO BE REMOVED DUE TO INFECTION. PHYSICIAN CALLED TO LET ME KNOW HE HAD REMOVED THE DEVICE. PATIENT IS A DIABETIC AND HAD BOTH LEGS AMPUTATED ABOVE THE KNEE PRIOR TO HAVING ENTERRA IMPLANTED. DEVICE WAS DISPOSED OF AT FACILITY.

  Patient problems: Unspecified Infection

  MAUDE report 22323322 ↗
• InjuryJun 24, 2025High impedance; Insufficient Device Problem Information; High impedance; Insufficient Device Problem Information

  PATIENT WENT TO SEE PROVIDER BECAUSE NAUSEA SYMPTOMS HAD RETURNED. ORIGINALLY IMPLANTED IN (B)(6) LAST (B)(6). IMPEDANCE WAS OUT OF RANGE AND PATIENT STATED THAT SHE HAD BEEN DOING A LOT OF HEAVY LIFTING RECENTLY. SURGEON SCHEDULED HER FOR A POSSIBLE LEAD/ BATTERY REVISION. WENT IN AND CHANGED THE BATTERY. PATIENT RETURNED BACK TO NORMAL IMPEDANCE RANGE. PATIENT IS TO FOLLOW UP WITH SURGEON IN 2 WEEKS.

  Patient problems: Failure of Implant

  MAUDE report 22322833 ↗
• InjuryJun 24, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENTS STIMULATOR HAS BEEN TURNED UP RECENTLY AND IT'S SHOCKING HER, CAUSING QUITE A BIT OF ISSUES. SHE HAS BEEN ADMITTED IN THE HOSPITAL FOR MALNUTRITION AND GETTING TPN.

  Patient problems: Electric Shock

  MAUDE report 22321695 ↗